(240 days)
The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discreet regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.
The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.
The provided text describes the 510(k) summary for the LuMend Percutaneous Catheter. It outlines the device, its intended use, and comparison to predicate devices, but it contains limited information about specific acceptance criteria and the detailed study that proves the device meets those criteria.
However, based on the information provided, here's an attempt to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance results. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Basic Functional Characteristics | "All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations." |
| Tensile Strength | "Included in vitro tensile strength" (No specific value or pass/fail criterion given) |
| Torqueability | "Included in vitro...torqueability" (No specific value or pass/fail criterion given) |
| Tip Flexibility | "Included in vitro...tip flexibility" (No specific value or pass/fail criterion given) |
| Coating Adherence/Integrity | "Included in vitro...coating adherence/integrity" (No specific value or pass/fail criterion given) |
| Torquability (repeated) | "Included in vitro...torqueability" (No specific value or pass/fail criterion given) |
| Biocompatibility | "Included in vitro...biocompatibility" (No specific value or pass/fail criterion given) |
The document mentions "internal specification requirements" and "external standard requirements and predicate performance expectations" as the benchmarks, but it doesn't elaborate on what these specific requirements or expectations were. It broadly states that "All data fell well within" these requirements.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "in vitro, in situ, and in vivo test data" but provides no details on the number of units tested for each.
The provenance of the data is not specified (e.g., country of origin). The testing seems to be conducted by the manufacturer, LuMend, Inc., likely within their own facilities or contracted labs. The studies are described as "Design analysis and in vitro data," along with some "in situ and in vivo" testing, suggesting a retrospective analysis of device performance against established standards rather than a prospective clinical trial with human subjects for efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of device performance, as one might see in diagnostic imaging studies. The testing described is focused on physical and mechanical properties of the catheter.
4. Adjudication Method for the Test Set:
Not applicable. The described testing is primarily objective measurement of physical properties against engineering specifications, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document describes testing of the device's physical and functional characteristics, not its impact on human reader performance or diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical instrument (a catheter), not a software algorithm.
7. The Type of Ground Truth Used:
For the "test set" (which appears to refer to the device units undergoing performance validation), the "ground truth" was based on:
- "internal specification requirements"
- "external standard requirements" (e.g., "Guidewire Guidance" Document – January 1995 and FDA standards)
- "predicate performance expectations"
These are essentially engineering specifications, regulatory standards, and performance benchmarks derived from the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical instrument (a catheter), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. See point 8.
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JAN 1 6 2002
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. KU11562
TBD 510(k) Number:
Applicant Information:
May 18, 2000 Date Prepared:
| Name: | LuMend, Inc. |
|---|---|
| Address: | 400 Chesapeake DriveRedwood City, CA 94063650-364-1400 |
| Contact Person: | Michael A. Daniel |
|---|---|
| Phone Number: | (415) 407-0223 |
| Facsimile Number: | (925) 932-5706 |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | LuMend Percutaneous Catheter - TBD |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Devices:
The LuMend Percutaneous Catheter is substantially equivalent in intended use and/or method of operation design and materials to a combination of the following predicate devices:
- ILTTM 0.014" Catheter (K001992), 1.
- Medtronic Zuma™ Guiding Catheters (K000677) and 2.
- Guidant Viking Optima™ Guiding Catheter (K001435) 3.
Device Description:
The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.
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(Continued)
Intended Use:
The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide I he Lunelia Perculancous Catholor is interest to see a very vasculature. It may be used to facilitate placement of guide wires and other interventional devices.
Comparison to Predicate Device(s):
The LuMend Percutaneous Catheter is substantially equivalent to a combination of the ILTTM
Collection of Cathere is not The The Catalian Catheters (K000677) and the The Luvicin's Cromanoous Cat.Mediconic Zuma™ Guiding Catheters (K000677) and the Guidant Viking Optima™ Guiding Catheter (K001435).
The LuMend Percutaneous Catheter is essentially identical to the ILTM 0.014" Catheter (K001992), in terms of intended use. Both devices are primarily intended to be used in (KU01392), in tenns of intended ass. "Dot access discreet regions of the vasculature prior confidition with a steeraore gates wire in other as been navigated and any lession to angloplasty and stemmy. "In oour cases only be exchanged and a balloon dilatation catheter may be immediately introduced.
The LuMend Percutaneous Catheter is similar in terms of shape, size, materials and construction The Luvicha i croutuneous Calleters used to provide guide wire and other catheter support and to common coronal y satiletels about is point the Medtronic Zuma™ Guiding Catheters guidance. Examples of the Guiding Catheter (K001435) in terms of size ranges, design, materials used, form and function.
In Vitro, In Situ and In Vivo Test Data:
Design analysis and in vitro data confirm that basic functional characteristics are substantially Dosign and in the predicate devices cited. Device evaluation consisted of testing specified in equivalent to the production Guidewire Guidance" Document – January 1995 and I'DA 3 Coronal J and Cercer strength, torqueability, tip flexibility, coating adherence/integrity, Included in viro tensity, corque bacagaility. All data fell well within, both, internal specification blocompanisms, as well as external standard requirements and predicate performance expectations.
Summary:
Based upon the product technical information, intended use, and performance information Dason apon this pre-market notification, the LuMend Percutaneous Catheter has been shown to be substantially equivalent to currently marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2002
Mr. Michael A. Daniel Regulatory and Clinical Affairs LuMend, Inc. 400 Chesapeake Drive Redwood City, CA 94063
K011562 Re:
LeMend Percuataneous Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: October 18, 2001 Received: October 18, 2001
Dear Mr. Daniel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Michael A. Daniel
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and in you to ough finding of substantial equivalence of your device to a legally prematics notification. "The Pressification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific ad 1.0 for in vitro diagnostic devices), please contact the Office of additionally 21 OF CF C F C F . F ar - 586. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1996. Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ans. Daniel Miller, M.D.
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4802 K011562 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
LuMend Percutaneous Catheter Device Name:
Indications For Use:
The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable The Luvielia Ferculancous Cathecer is antone of the coronary vasculature. It may be used guide wire in order to access assires and other interventional devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oak Th
Division of Cardiovascular & Respiratory Devicze
510(k) Number K011362
ﺳ Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).